Thyroid Hormones Treatment in Asthma Exacerbation (THINAS)
Is There a Role for Thyroid Hormones Treatment in the Set-up of Acute Moderate to Severe Asthma Exacerbation
This study will explore whether supplementation with thyroid hormones in the set-up of asthma exacerbation could improve the clinical outcomes.
The study will include adults admitted to Rambam health care campus for moderate to severe Asthma exacerbation.
The study is a prospective, randomized, double-blind, placebo-controlled, clinical trial. Patients will be randomized on admission to receive treatment with intra-venous thyroxine (100mcg once on admission and additional 100mcg after 12 hours) or placebo. The study treatment will be given only after the initial bronchodilator therapy, oxygen and informed consent are given. The primary endpoint is the time to return of the peak expiratory flow (PEF) rate to normal values or personal base line.
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Haifa、以色列、31096
- Rambam Health Care Campus
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18 years of age or older
- Known Asthma
- The exacerbation is defined as moderate or severe.
- Not currently enrolled as an active participant in another clinical trial of a medical therapy or device.
- The patient or first degree family relative (in cases where the patient is intubated) has authorized his/her consent to participate in this trial. The patient will be asked to give his consent only after initial bronchodilator therapy
Exclusion Criteria:
- 60 years of age or older
- Known thyroid disorders
- Subject where thyrotoxicosis is suspected
- Known heart disease
- Heart rate > 140
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:IV thyroxin
|
Patients will receive treatment with intra-venous thyroxine 100mcg once on admission and additional 100mcg after 12 hours.
其他名称:
|
|
安慰剂比较:control IV saline
Placebo
|
Patients will receive treatment with normal saline 100ml once on admission and additional 100ml after 12 hours
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
time to normalization of PEF (peak expiratory flow)
大体时间:one week
|
The primary endpoint is the time to return of the PEF rate to normal values or personal base line.
|
one week
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Length of stay
大体时间:one week
|
• Length of stay (in cases of hospitalization in the internal medicine departments) or length of intubation (in cases of hospitalization in the MICU).
|
one week
|
|
Time to oxygenation
大体时间:one week
|
Time to oxygen saturation > 95% (while breathing spontaneously and without oxygen supplements)
|
one week
|
|
heart rate
大体时间:one week
|
Time to normalization of heart rate
|
one week
|
|
respiratory rate
大体时间:one week
|
Time to normalization of respiratory rate
|
one week
|
合作者和调查者
调查人员
- 首席研究员:Zaher S Azzam, prof.、Rambam Health Care Campus
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.